RecallRadar

FDA Drug recall D-0002-2015

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, I…

On 2014-10-08 the FDA classified a Class I recall of Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, I… by Hospira, citing presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0002-2015
ClassificationClass I
Statusterminated
Initiated2014-06-17
Published2014-10-08
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29

Reason

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Identifiers

ndc0409-1559-18
ndc0409-1559-10
ndc0409-1559-19
ndc0409-1559-30
ndc0409-1560-18
ndc0409-1560-10
ndc0409-1560-19
ndc0409-1560-29
ndc0409-1582-18
ndc0409-1582-10
ndc0409-1582-19
ndc0409-1582-29
ndc0409-1587-50
ndc0409-1610-50
ndc0409-1746-70
ndc0409-1746-10
ndc0409-1746-71
ndc0409-1746-30
ndc0409-1749-70
ndc0409-1749-10
ndc0409-1749-71
ndc0409-1749-29
ndc0409-1752-50
ndc0409-1755-50
ndc0409-2510-01
ndc0409-2510-25
ndc0409-7535-01
ndc0409-7535-25
ndc0409-1250-01
ndc0409-1250-25
ndc0409-5010-01
ndc0409-5010-25
ndc0409-1530-01
ndc0409-1530-25
ndc0409-0525-01
ndc0409-0525-25
ndc0409-7510-01
ndc0409-7510-25
ndc0409-2253-01
ndc0409-2253-25
code_infoLot # 33-545-DD, Exp. 09/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0002-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.